Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain

NCT07674901 | Not Yet Recruiting FDA Device

• 1 other identifier: WCG IRB Study Number 1404409
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this superiority randomized controlled trial is to evaluate the effect of daily knee sleeve use on 5-year radiographic knee osteoarthritis progression and knee-related symptoms in older adults with chronic knee pain. The investigators will recruit 235 individuals aged 50-64 years at baseline with chronic (≥ 3 months) knee pain, randomized to daily use of an elasticized fabric knee sleeve versus no knee sleeve use. Participants will have knee radiographs at baseline and year 5 and will complete a survey including Knee injury and Osteoarthritis Outcome Score (KOOS) subscales for pain, knee function and quality of life at 3 months and annually. A prespecified interim analysis of the 1-year KOOS subscore data will be performed.

Conditions

Knee Arthritis, Osteoarthritis

Keywords

Osteoarthritis; Arthritis; Joint, Knee; Osteoarthritis, Knee; Pain, Musculoskeletal

Outcome Measures

Primary Outcomes (1)

• Change in radiographic grade of knee osteoarthritis severity

  Kellgren-Lawrence radiographic grade 0 (best) to 4 (worst) on standing/weightbearing anterior/posterior (A/P) knee radiograph

  Change from baseline at 5 years

Secondary Outcomes (3)

• Change in knee pain

  Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

• Change in knee function

  Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

• Change in knee-related quality of life

  Change from baseline at 1 year (also assessed at 3 months and annually years 2-5)

Other Outcomes (2)

• Proportion of participants with incident arthroscopic knee procedure or knee replacement surgery

  Change from baseline at 5 years

• Proportion of participants with patellar instability

  Change from baseline at 5 years

Study Arms (2)

Knee sleeve

EXPERIMENTAL

Daily knee sleeve use

Device: Knee sleeve

Control

NO INTERVENTION

No knee sleeve use

Interventions

Knee sleeve DEVICE

Daily use of one of the following: * Mueller 4-way Stretch Knee Support * Mueller FIR Knee Support * PhysFlex Knee Brace

Knee sleeve

Eligibility Criteria

• Age: 50 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aged 50-64 years at the time of his/her baseline eligibility screening
• Unilateral or bilateral chronic (≥ 3 months) knee pain
• Knee circumference between 12" (30 cm) and 22" (56 cm) measured over center of kneecap; or if a larger size is needed, thigh circumference up to 28" (71 cm) measured at 4" ABOVE center of knee cap per manufacturers' size specifications for the knee sleeves used in the intervention
• English-speaking and able to provide informed consent for study participation

You may not qualify if:

• History of knee replacement surgery in the painful/affected knee(s)
• Knee replacement surgery or arthroscopic procedure scheduled or anticipated in the affected knee(s) within 1 year after study eligibility screening
• Self-reported history or medical documentation of rheumatoid arthritis, psoriatic arthritis or other inflammatory arthritis in any joint; peripheral arterial disease or other vascular or circulatory disorder; blood clotting disorder; bleeding disorder or self-reported easy bruising; current treatment with an anticoagulant or antiplatelet agent; immobility; nonambulatory status; knee ligament tear or rupture; or lower extremity fracture requiring internal or external fixation within 1 year before study eligibility screening
• History of unprovoked falls
• Current use of a rigid or hinged knee brace made of metal, plastic or fiberglass, or prescription for a knee brace for the affected knee(s)
• Previous use of a knee sleeve/fabric knee support on the affected knee(s) for over 6 months cumulative time
• Inability to pull on or remove elasticized knee sleeve from affected knee(s)
• Kellgren-Lawrence (KL) grade 4 on a baseline standing/weightbearing A/P knee radiograph of the affected knee(s) is excluded because it is the highest KL grade, so a primary outcome event (transition to a higher grade) is impossible.
• Moderate to severe knee effusion on baseline radiographs of the painful knee(s) is excluded due to the potential risk of harm and discomfort from the compressive effect of a knee sleeve. Individuals with moderate to severe knee effusion during the first screening assessment who are otherwise eligible will be invited to have a repeat A/P knee x-ray 2 months later to reassess radiological eligibility. If the effusion is mild or has resolved by that time, the individual will be invited to enroll in the study.
• Pregnancy (because of x-ray exposure)
• Cannot attend a 5-year study assessment for follow-up knee radiographs
• Investigator discretion

Sponsors & Collaborators

• Margaret L Gourlay, MD, MPH: lead
• Knee Sleeve Trial Collaborative, LLC: collaborator

Study Sites (1)

RAYUS Radiology

Springfield, Massachusetts, 01107, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Arthritis; Osteoarthritis, Knee; Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Margaret L Gourlay, MD, MPH

  Knee Sleeve Trial Collaborative, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret L Gourlay, MD, MPH

CONTACT

413-213-4655; info@kneesleevetrial.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research Radiologist (Assessor of Primary Outcome and other radiographic outcomes) is masked to the randomization assignments
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Superiority Randomized Controlled Trial

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: July 1, 2026

Record last verified: 2026-06

Locations

US (1)